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Madrigal Pharmaceuticals Provides Corporate Updates and Reports 2022 Fourth Quarter and Full Year Financial Results
Positive Phase 3 MAESTRO-NASH study results reported in December 2022 position Madrigal for a resmetirom new drug application filing in the first half of
About this update from Madrigal Pharmaceuticals, Inc.
[{"type":"text","content":"Positive Phase 3 MAESTRO-NASH study results reported in December 2022 position Madrigal for a resmetirom new drug application filing in the first half of 2023Madrigal reports year end cash, cash equivalents and marketable securities of $358.8M CONSHOHOCKEN, Pa., Feb. 23, 2023 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), today provides a summary of corporate updates and reports fourth quarter and full year 2022 financial results. Paul Friedman, M.D., Chief Executive Officer of Madrigal, stated, “The positive Phase 3 MAESTRO-NASH results reported in Q4 2022 have allowed us to advance our regulatory filing preparations, accelerate our prelaunch market development programs, and strengthen our financial position with funding to support the company’s operations through the potential accelerated approval of resmetirom in the U.S. The results have also reinforced our conviction in the value of resmetirom. The Institute for Clinical and Economic Review (ICER), a non-profit organization that conducts pharmacoeconomic assessments of new therapies, recently published a draft Evidence Report indicating that resmetirom has the potential to be a cost-effective treatment for NASH patients with significant fibrosis.” Becky Taub, M.D., Chief Medical Officer and President of Research & Development of Madrigal, stated, \"We remain on track to file our NDA for resmetirom in the first half of 2023. The filing will be supported by positive Phase 3 biopsy results, a standalone Phase 3 safety study, and two ongoing outcomes studies designed to verify clinical benefit following accelerated approval. Based on current screening and enrollment trends, we anticipate that the 54-month outcomes portion of MAESTRO-NASH will be fully enrolled prior to NDA filing in the first half of 2023. We believe that data from the 52-week liver biopsy primary endpoints of MAESTRO-NASH, in which both the NASH resolution and fibrosis reduction primary endpoints were achieved, support NDA and market authorization filings for accelerated approval in the U.S. and Europe. In addition, the noninvasive data from MAESTRO-NASH will provide a framework for identification and monitoring of patients treated with resmetirom in real world clinical practice fo...